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Use of Electronic Personal Health Records to Improve Medication Adherence

This study has been completed.
Sponsor:
Collaborator:
Centers for Medicare and Medicaid Services
Information provided by (Responsible Party):
Michael Mirro, Parkview Health
ClinicalTrials.gov Identifier:
NCT03018197
First received: January 10, 2017
Last updated: January 10, 2017
Last verified: January 2017
  Purpose
The purpose of this pilot study is to examine the use of a personal health record to improve medication adherence among patients with non-valvular atrial fibrillation taking dabigatran for primary prevention of embolic stroke.

Condition Intervention
Atrial Fibrillation
Medication Adherence
Other: Medication Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Parkview Health:

Primary Outcome Measures:
  • Medication Adherence evaluated through medication possession ratios [ Time Frame: 3 months during study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Engagement evaluated through Patient Activation Measure (PAM) [ Time Frame: 3 months during study ] [ Designated as safety issue: No ]
  • Medication Knowledge evaluated through 5-question survey [ Time Frame: 3 months during study ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2014
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
Other: Medication Education
Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
No Intervention: No Medication Education
Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.

Detailed Description:

Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.

Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patient of Parkview Physicians Group-Cardiology
  • Currently on dabigatran for non-valvular atrial fibrillation
  • Out-patient status
  • Ability to read and understand English
  • Access to the Internet
  • Ability to utilize the computer and Internet
  • Willingness to enroll in a MyChart account

Exclusion Criteria:

  • Physical or cognitive disability hindering provision of the informed consent process or performance of study tasks
  • Unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record
  • Designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation
  • Currently part of another study involving another type of personal health record (other than MyChart)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018197

Locations
United States, Indiana
Parkview Research Center; Parkview Health
Fort Wayne, Indiana, United States, 46845
Sponsors and Collaborators
Parkview Health
Centers for Medicare and Medicaid Services
Investigators
Principal Investigator: Michael Mirro, MD Parkview Health
Principal Investigator: Ozlem Ersin, PhD Manchester University College of Medicine
  More Information

Responsible Party: Michael Mirro, Chief Academic and Research Officer, Parkview Health
ClinicalTrials.gov Identifier: NCT03018197     History of Changes
Other Study ID Numbers: PRC13-0806 ePHR AFib pilot 
Study First Received: January 10, 2017
Last Updated: January 10, 2017
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available.

Keywords provided by Parkview Health:
Personal Health Record
Medication Knowledge
Anticoagulants
Patient Engagement

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 17, 2017